Anti-Diarrheal

Product NDC: 62011-0390
Requested package NDC: 62011-0390-1
11-digit product format: 620110390
Labeler code: 62011
Product ID: 62011-0390_dfc6d50d-e754-c868-e053-2a95a90aafa8
Type: HUMAN OTC DRUG
Nonproprietary name: LOPERAMIDE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: NDA021855
Marketing category: NDA
Marketing start: 2018-12-15
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021855-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL		RLD	2005-08-04
N021855-002	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL		RLD, RS	2005-08-04

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021855-001	LOPERAMIDE HYDROCHLORIDE	1MG	CAPSULE / ORAL	RLD	2005-08-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021855-002	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	RLD, RS	2005-08-04	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Anti-Diarrheal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
77TI35393C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
978006	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1537febf-2816-438b-979a-8c8f16f06de5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62011-0390-1	Anti-Diarrheal	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		3
62011-0390-1	Anti-Diarrheal	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0390	ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20220525_1537febf-2816-438b-979a-8c8f16f06de5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	04a35525-ae8e-b41e-e063-6294a90ab10e	2026-04-20	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CVS Pharmacy, Inc.	60bc8f05-f35e-45e0-ba3b-c82a87d60f5b	2026-02-27	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Imodium A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	31bfcbb4-c58c-4edc-ac68-356a448b7507	2025-12-22	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	WALGREENS	50814751-8bee-4768-bf6c-e9da3400090b	2025-12-15	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	TARGET Corporation	ee8a6bdf-847e-4b88-8aea-6d3daa669994	2025-12-12	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	MEIJER DISTRIBUTION INC	440fb3ce-4106-4169-b187-cfbfdd2f42c1	2025-12-11	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	35a938af-decf-5b5d-e063-6294a90a9ab0	2025-05-21	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	35aa2daf-3486-7ee2-e063-6394a90ad473	2025-05-21	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Albertsons Companies	1d4ec76d-ff0d-a55d-e063-6294a90ae22c	2025-04-07	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	DISCOUNT DRUG MART, INC.	ed28814d-9733-46ff-930f-b148e31f2f51	2024-12-23	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	KROGER COMPANY	ff5dcb48-318c-4f2a-8df2-73ff6dd2a49e	2024-12-23	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	17035ff7-8ba8-131c-e063-6394a90af5ea	2024-10-03	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CARDINAL HEALTH	bd58d6e9-628c-4c6b-b44c-da95e0417ba7	2024-05-31	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	a14bd404-cc79-06e0-e053-2a95a90a6841	2023-12-26	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	fed347ad-cfbb-9ee8-e053-6394a90ad275	2023-10-10	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES	f9e03d2b-2ec0-322b-e053-6394a90a1599	2023-04-21	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	TOP CARE (Topco Associates LLC)	c62bc8d4-0857-16fc-e053-2a95a90a0c41	2022-12-30	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
ANTI-DIARRHEAL	LOPERAMIDE HYDROCHLORIDE	Northeast Pharma	c2db4155-68d4-71be-e053-2a95a90a7f35	2022-12-30	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Premier Value Alliance LLC	0dd97bfb-67ce-472f-9b23-15f613bb3135	2022-12-29	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Wal-Mart Stores, Inc.	507acd63-b2b4-465e-bb94-2d66724de20a	2022-12-29	Warnings	Exact identifier application applno (NDA): 021855 application number: NDA021855

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978006	loperamide HCl 2 MG Oral Capsule	PSN	1537febf-2816-438b-979a-8c8f16f06de5	3
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	1537febf-2816-438b-979a-8c8f16f06de5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62011-0390-1	62011039001	2 BLISTER PACK in 1 CARTON (62011-0390-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2018-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Strategic Sourcing Services LLC \| Bionpharma Inc. \| Patheon Softgels Inc.	2022-05-24	HUMAN OTC DRUG LABEL	3